On Wednesday, the FDA accepted GSK plc's (NYSE:GSK) marketing application seeking approval for gepotidacin, an investigational, oral antibiotic for adult and adolescent females with uncomplicated urinary tract infections (uUTIs).
The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of March 26, 2025.
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Over half of all women are affected by uUTIs in their lifetime, with approximately 30% suffering from recurrent disease.
New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates.
Gepotidacin is a late-stage antibiotic in GSK's growing infectious disease portfolio and could be the first in a new class of oral antibiotics for uUTIs in over 20 years.
The application is supported by data from phase 3 EAGLE-2 and EAGLE-3 trials.
In these studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin.
In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin, demonstrating therapeutic success in 58.5% of participants compared to 43.6% for nitrofurantoin.
In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% of participants compared to 47.0% for nitrofurantoin.
The development of gepotidacin has been partially funded by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).
Price Action: GSK stock is up 0.40% at $39.12 at last check Wednesday.
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